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IBC’s 8th Annual
Register Early and Save Up to USD400! www.IBCLifeSciences.com/AsiaTIDES
February 24-26, 2016 • Westin Miyako Kyoto • Kyoto, Japan
The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss
current strategies and trends to accelerate promising molecules from research to commercialization
世界中のオリゴヌクレオチドとペプチドのグローバルリーダー達が一堂に会するアジア唯一のイベン
トで、前途有望な分子の研究から商業化までを加速するために、現在の戦略と傾向を話し合います。
Duchenne Muscular Dystrophy
Once-Weekly Peptide: Semaglutide
Challenge to be a Global
Pharma Innovator
Exon-skipping Therapies
Constrained Peptides and
Peptide-Based Drug Design
Locked Nucleic Acids
Global Experts Help Accelerate Your Molecules to Market
Joji Nakayama
Daiichi Sankyo, Japan
Masafumi Matsuo, M.D., Ph.D.
Kobe Gakuin University, Japan
Keiichi Masuya, Ph.D.
PeptiDream Inc., Japan
Troels Koch, Ph.D.
Roche Innovation Center
Copenhagen, Denmark
Shin'ichiTakeda, M.D., Ph.D.
National Center of Neurology
and Psychiatry, Japan
Jesper Lau, Ph.D.
Novo Nordisk A/S, Denmark
Media Parters: Organized by:
n Optimize the drug-like properties of your molecule for accelerated approval
• Phase 2/3 case studies • Delivery/formulation • Conjugates • Novel discoveries
n Discover CMC techniques and analytical strategies for complex molecules
• Large & small scale • Cost reduction • Novel synthesis • Lifecycle management
n Reach new markets & find partners for your molecules, technologies and services
•Innovation & investment landscape • Regulatory perspectives • Networking dinner
Dear Colleagues:
AsiaTIDES is Asia-Pacific’s leading oligonucleotide and peptide
therapeutics event for discovery, clinical and CMC scientists to share
best practices and success factors to help you accelerate molecules
from research to commercialization. The international speaker faculty
represents companies from the US, Europe, Japan, Australia and APAC
and provides a comprehensive update on the global progress of
oligonucleotides and peptides in development, so you can benchmark
your own programs and find new ideas to improve the development
of your products.
In response to your requests, this year’s program includes more
preclinical and clinical case studies than ever before from industry
bellwether companies including:
• Isis Pharmaceuticals
• Alnylam
• Novo Nordisk
• Roche
• Daiichi Sankyo
• Polyphor
• Sarepta Therapeutics
• CanBas
• Dicerna
• PeptiDream
• Noxxon
• miRagen Therapeutics
• Zealand Pharma
• and many more….
I encourage you to register today and maximize the value of attending
AsiaTIDES in Kyoto by participating in these additional activities:
• Share and find new research in the poster sessions
• Evaluate new products and services in the exhibit hall
• Find collaborators during the networking breaks, lunches,
networking dinner and cocktails
• Take an extra day to explore the historic and beautiful city of Kyoto
Sincerely,
Michael P. Keenan
Project Manager and Producer
Your International AsiaTIDES Advisory Committee
Robert Hagopian, Director Business Development, PolyPeptide Laboratories, USA
Yusuke Kohno, Vice President, Jitsubo Co Limited, Japan
Shawn Lee, Ph.D., President and CEO, CPC Scientific, USA and China
Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and CEO  Founder, OliX
Pharmaceuticals, Korea
Patrick Lu, Ph.D., Founder, President and CEO, Sirnaomics, Inc., USA
Michael McGinley, Manager, Core Products, Phenomenex, USA
Bruce Morimoto, Ph.D., Executive Director Applied Translational, Medicine, Drug
Development Services, Celerion, USA
El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium
Hideaki Sato, General Manager, Technical Support and Marketing, GeneDesign, Inc.,
Japan
Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo, Japan
Dmitry Samarsky, Ph.D., SVP, International Business and Technology Development,
RiboBio, China
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
Daisuke Takahashi, Ph.D., Manager, Bio-functional Molecular Chemistry Group,
Research Institute for Bioscience Products  Fine Chemicals, Ajinomoto Co., Inc.,
Japan
	 2	 To Register, Call: (+65) 6508 2401  • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
Accelerate Your Oligo and Peptide Molecules to Market
Meet the People Behind the Products and Get
the AnswersYou Need
The AsiaTIDES Exhibit Hall will give you the opportunity to find the
technologies and services you need to accelerate research, discovery
efforts and clinical programs. Visit vendor booths to discuss new product
advancements, network with industry and academic researchers, engineers
and executives during scheduled luncheons and receptions, or spend time
at the popular and innovative Poster Sessions. See more details on page 7.
Call for Posters
Limited space is available for poster presentations at this event.
If you have new results/data on topics relevant to this conference, we
encourage you to submit a poster abstract for consideration.
To present a poster, complete the conference registration form and
submit poster title and one page poster abstract online at
www.IBCLifeSciences.com/AsiaTIDES by January 27, 2016.
See registration form for poster fees.
The Westin Miyako Kyoto
1 Awataguchi Kachocho, Higashiyama-ku, Kyoto 605-0052, Japan
Tel: +81-75-771-7111 • Fax: +81-75-751-2490
Website: http://www.miyakohotels.ne.jp/westinkyoto/english/index.html/
Special Room Rates for AsiaTIDES Attendees: 
JPY 19440/JPY 21600 (Superior Single/Twin) •JPY 25960/JPY 28080 (Deluxe Single/Twin)
To book a room at the Westin Miyako Hotel at the special AsiaTIDES group rate, please
reserve your room by visiting the hotel section at www.IBCLifeSciences.com/AsiaTIDES
Main Conference • Concurrent Tracks Wednesday, February 24, 2016
Oligonucleotides in Preclinical and
Clinical Development
	11:00 	Chairman’s Remarks
Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA
	11:15 	Stabilization and Activation of Double-stranded Nucleic
Acid Drugs by Artificial Cationic Molecules
We have developed novel cationic oligosaccharides and cationic peptides that
selectively bind to A-type RNA/RNA and DNA/RNA duplexes. In this presentation,
I would like to describe the synthesis and properties of these unique molecules
as carriers and stabilizers of siRNA drugs and antisense DNA/RNA heteroduplexes.
Takeshi Wada, Ph.D., Professor, Department of Medicinal and Life Science,
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Japan
	11:45 	Defining the Relationship between ASGR Binding and
Activity for GalNAc-ASO Conjugates
A fluorescence polarization competition assay was established to determine
the influence of GalNAc valency, ASO length, backbone composition and
charge on ASGR binding. Results gained from this approach were correlated
to ASO activity in hepatocytes and mice. Our work provides insights into the
interactions of ASO-conjugates with cell-surface receptors and on functional
uptake of ASOs into cells and tissues.
Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA
	12:15 	Networking Luncheon with Exhibit and Poster Viewing
	 1:30 	Presentation Sponsorship Opportunity
For more information about sponsoring a drug development case study,
application or technology presentation in this session, please contact
Patrick Gallagher at pgallagher@ibcusa.com.
	 2:00 	PreclinicalTherapeutic Development againstTopical
Diseases Using Cell Penetrating, Asymmetric RNAiTriggers
Cell penetrating, asymmetric siRNA (cp-asiRNA) is an asymmetric RNAi trigger
with simple combination of chemical modifications. cp-asiRNA enters into cells
and triggers target gene silencing via RNA interference without the need of
delivery vehicle. Preclinical therapeutic development against skin, eye and lung
diseases using cp-asiRNA platform will be presented.
Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and Founder and
CEO, OliX Pharmaceuticals, Korea
Featured Presentation
	 2:30 	Activity Determinants of Locked
Nucleic Acids 
Small structural modifications of antisense oligonucleotides
can have significant effects on structure/activity relations. The
underlying nature of these subtle relationships cannot be
understood from a reductionist view point. We have employed
a new modelling strategy to get a better understanding on how
the structural units can impact the properties of LNA.
It will be presented how new chemical modifications and designs can improve
central therapeutic parameters of LNA.
Troels Koch, Ph.D., VP  Head of Research, RNA Therapeutics,
Roche Innovation Center Copenhagen, Denmark
	 3:00 	Networking Refreshment Break with Exhibit and Poster Viewing
Peptide Discovery
	11:00 	Chairman’s Remarks
Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine,
Drug Development Services, Celerion, USA
	11:15 	Oral Equivalents of Monoclonal Antibodies:
Exploitation of Constrained Peptides
This presentation will briefly describe platform technology and focus on
optimization of the oral delivery of constrained peptides, that are alternatives
to marketed antibodies Stelara and Entyvio, for treatment of IBD. The
presentation will describe rodent and monkey data, and criteria for selection
of IND candidates which should enter the clinic in 2015 and early 2016.
Mark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics,
Australia
	11:45 	Presentation Title TBA
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Speaker TBA, Waters
	12:15 	Networking Luncheon with Exhibit and Poster Viewing
Drug Delivery Strategies for Peptides
	 1:30 	Delivery Strategies for Peptides in Clinical Development
This presentation will include a brief overview of technologies available for
subcutaneous injection replacement, injectable sustained release formulation,
half-life extension and non-invasive delivery. The challenges and opportunities
for each of these approaches will be clarified. In addition, a pathway for clinical
development of a new peptide will be discussed along with strategy and
timing for incorporating life cycle options.
Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts, USA
	 2:00 	Peptide Mediated Delivery of Bioactive Proteins into Cells
Numerous approaches have been reported up to the present time for
intracellular delivery. However, approaches are still needed that have improved
efficacy in delivering high-molecular-weight proteins into cytosol to obtain
enhanced bioactivity. By modifying sequences of natural hemolytic peptides,
we have succeeded in creating a peptide, which has a low cytotoxicity but has
a high ability to yield a marked cytosolic release of endocytosed proteins.
Shiroh Futaki, Ph.D., Professor, Institute for Chemical Research,
Kyoto University, Japan
	 2:30 	Biodegradable Silica Based Delivery of
Therapeutic Peptides
Biodegradable silica is a powerful drug delivery matrix for sustained release of
parenteral therapeutics. Encapsulation of peptides in nanoporous silica provides an
effective tool to administer peptides in a controlled manner even for several months.
The presentation describes the basics of silica technology with several case studies.
Lasse Leino, Ph.D., Adjunct Professor and CEO, DelSiTech Ltd., Finland
	 3:00 	Networking Refreshment Break with Exhibit and Poster Viewing
	 Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 	 3
Main Conference • Plenary Session Wednesday, February 24, 2016
Keynote Presentation
	 9:15 	Therapeutic Approaches to Duchenne
Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is the most common
childhood genetic disease, affecting one in 3,500 newborn boys,
causing progressive muscle weakness, heart and respiratory
failure and premature death. This disease is caused by the
mutations of the DMD gene, and no cure exists for this disease, but a number
of promising new molecular therapies are being intensively studied. Among
them, exon skipping by antisense oligonucleotides is a novel method to
restore the reading frame of the mutated DMD gene, and rescue dystrophin
expression. I will present the recent progress of therapy of the disease.
Shin'ichi Takeda, M.D., Ph.D., Director General, National Institute of
Neuroscience, National Center of Neurology and Psychiatry, Japan
Keynote Presentation
	 9:45 	Paradigm Shift in Drug Discovery:
Constrained Peptides and
Peptide-Based Drug Design
Constrained peptides represent highly valuable chemical
matter for use in biological validation, identifying hit/lead
molecules for drug discovery, and also directly as peptide
therapeutics. Our in-house approach to the optimization of constrained
peptides, and how these peptides contribute to hit finding for difficult target
classes from a general perspective will be introduced.
Keiichi Masuya, Ph.D., Chief Operating Officer, PeptiDream, Inc., Japan
	 8:15 Registration and Coffee
	 9:10 Chairman’s Remarks Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia
	 10:15 Networking Refreshment Break with Exhibit and Poster Viewing
Main Conference • Concurrent Tracks  Wednesday, February 24, 2016(continued)
	 4	 To Register, Call: (+65) 6508 2401  • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
	 3:45 	Daiichi-Sankyo’s Strategies and Experiences in Biologics
focused Oligonucleotide Drug Development
This presentation will discuss Daiichi-Sankyo’s progress in the development of
biologics especially oligonucleotide drugs. Lessons learned to date, technical
challenges experienced and future approaches to progress our oligonucleotides
drugs as an important part of our biologics pipeline will be presented.
Junichi Koga, Ph.D., Corporate Officer and Global Head of Biologics,
Daiichi Sankyo, Japan
	 4:15 	ALN-HBV, An Investigational RNAi Drug for the
Treatment of Chronic Hepatitis B
Chronic hepatitis B infection is a serious liver disease impacting 400 million
people worldwide. Clinical manifestations are severe, and an estimated 1
million people die each year from the disease and its complications. With
today’s medicines, the cure rate for chronic HBV infection is less than 10%.
An RNAi therapeutic inhibiting all steps of the HBV life cycle and silencing
tolerogenic viral antigens has the potential to achieve a“functional cure.”
Laura Sepp-Lorenzino, Ph.D., Vice President, Entrepreneur-in-Residence,
Alnylam Pharmaceuticals, USA
	 4:45 	Eteplirsen a Drug for Duchenne Muscular Dystrophy
DMD, a neuromuscular disease, affects ~1:3500 of newborn boys and
invariably leads to their untimely death. DMD is most commonly caused
by deletions in the DMD gene that disrupt the mRNA reading frame and
prevent translation of dystrophin, an essential muscle protein. In ongoing
trials, eteplirsen, a morpholino oligomer, has been shown to restore the mRNA
reading frame and induce production of dystrophin. This treatment led to
significant benefit in the six-minute walk test.
Ryszard Kole, Ph.D., Distinguished Scientist, Sarepta Therapeutics, USA
	 3:45 	Phylomer Derived Cell Penetrating Peptides Facilitate
More Efficient Delivery of Peptides and Proteins to
the Cytoplasm
Phylomer peptide libraries have been screened for new cell penetrating peptides
for delivery of macromolecules and nanoparticles into cells. A novel genetic
screen known as the‘endosome escape trap’enables the isolation of rare CPP’s
which more efficiently deliver their cargoes to the cytoplasm. Some of these
cell penetrating Phylomers can be targeted to particular cell types. Phylogica has
developed a variety of functional assays to determine the extent of cytoplasmic
delivery of peptide and protein cargoes to the cytoplasm or nucleus. These
assays have shown Phylomer CPP’s to be 37-160 times more efficient than
TAT which can be active in vivo. These tools are now being applied in screens
targeting transcription factor oncoproteins such as cMyc NMyc and STAT5 as well
as for more efficient intracellular delivery of protein toxin conjugates.
Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia
	 4:15 	An Improved Transdermal Patch of Teriparatide Using
Ionic Liquid Transdermal System (ILTS)
Teriparatide is a recombinant parathyroid hormone used in the treatment
of osteoporosis and approved as a subcutaneous injection. A transdermal
patch which delivers teriparatide is being developed using Ionic Liquid
Technology. A series of in vitro rat skin permeation tests and in vivo rat PK
studies have been conducted which led to selection of a formulation which
demonstrated a temporary increase in the concentration of teriparatide in the
blood. Additionally, dermal irritation tests confirmed that there was no dermal
irritation to the rat skin.
Tatsuro Moriyoshi, Researcher, RD Department, MEDRx Co. Ltd., Japan
Panel Discussion
	 4:45 	Drug Delivery Systems and Strategies
Moderator: Bruce Morimoto, Ph.D., Executive Director Applied Translational
Medicine, Drug Development Services, Celerion, USA
5:15 Networking Reception in Exhibit and Poster Hall Co-sponsored by: and
Main Conference • Plenary Session Thursday, February 25, 2016
	 8:30 	Registration and Coffee
	 8:55 	Chairman’s Remarks
William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA
The Innovation and Investment Landscape
in Japan and China
	 9:00 	The Japan Landscape of Investment and Innovation in
Oligonucleotide and Peptide Development
INCJ is a public-private investment fund which provides financial and
management support for next-generation businesses including innovative
drug development. This presentation will provide an overview of the
investment and innovation landscape in Japan as well as discuss the
future potential of and opportunities in oligonucleotide and peptide drug
development in Japan.
Koichi Ashida, Executive Managing Director, Innovation Network of
Japan, Japan
	 9:30 	Development and Production of Therapeutic
Oligonucleotides in China
There is a growing interest towards oligonucleotide-based therapeutics among
drug developers in China. The field, however, still remains at relatively early
stages. This presentation will summarize current status of oligonucleotide
therapeutic programs. It will also outline the situation with the oligonucleotide
manufacturing capabilities in China. Finally, a summary of the recently introduced
by CFDA changes to the overall drug development process and procedures in
the country will be presented.
Dmitry Samarsky, Ph.D., SVP, International Business and Technology
Development, RiboBio, China
Keynote Presentation
	10:00 	Exon-skipping Therapy Advancing
Oligonucleotide Drug Development
This presentation will describe continued efforts in our laboratory
to exploit exon-skipping oligonucleotides to treat a variety of
diseases. Current progress and ongoing challenges of exon-
skipping will be discussed. An update on the learnings from
clinical studies in DMD patients will also be presented.
Masafumi Matsuo, M.D., Ph.D., Professor, Department of Medical Rehabilitation,
Kobe Gakuin University, Japan
	10:30 	Networking Refreshment Break with Exhibit and Poster Viewing
Oligonucleotides in Preclinical and
Clinical Development (continued)
Drug Delivery Strategies for Peptides (continued)
	 6:45 	Networking Dinner in Kyoto
Join fellow attendees in a fantastic networking and dining opportunity at a
local restaurant in beautiful Kyoto. Space is limited and an additional fee applies.
Please indicate when you register if you plan to join the dinner.
Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 	 5
Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued)
	11:10 	Chairperson’s Remarks
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG,
Germany
	11:15 	Clinical Efficacy of AZD9150, a Next Generation,
Constrained Ethyl Modified Antisense Oligonucleotide
Inhibitor of STAT3 – Tumor Cell Autonomous and
Immuno-modulatory Activity
AZD9150 is a next generation ASO that has demonstrated robust single
agent efficacy in several tumor types in phase I clinical studies. Preclinical and
clinical data suggest the activity of AZD9150 is mediated by both tumor cell
autonomous effects as well as through modulation of the immunosuppressive
microenvironment through the inhibition of STAT3 in tumor-associated
immune cell populations.
A.Robert MacLeod, Ph.D., Vice President Oncology and Exploratory
Discovery, Isis Pharmaceuticals, USA
	11:45 	Mirror-image Oligonucleotide Aptamers Inhibiting the
Chemokine CXCL12/SDF-1 - From Identification to Phase
IIa Data
SDF-1/CXCL12 is a pro-angiogenic chemokine that plays a major role in
homing processes of stem cells and malignant stem cells. Furthermore,
the chemokine also interacts with two receptors, i.e. CXCR4 and CXCR7.
We have identified a high affinity mirror-image oligonucleotide (NOX-A12,
olaptesed pegol) that neutralizes SDF-1's interactions with both receptors.
The compounds showed intriguing efficacy in different oncology models.
Currently, the substance is profiled in two Phase IIa studies in patients with
multiple myeloma and chronic lymphocytic leukemia.
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG,
Germany
	12:15 	Networking Luncheon with Exhibit and Poster Viewing
	 1:30 	DNA/RNA Heteroduplex Oligonucleotide as a Novel
Concept of Therapeutic Oligonucleotide
We develop a short DNA/RNA heteroduplex oligonucleotide (HDO) with a
structure different from double-stranded RNA used for short interfering RNA
and single-stranded DNA used for ASO. A DNA/lockednucleotide acid gapmer
duplex with an a-tocopherol-conjugated complementary RNA (Toc-HDO) is
significantly more potent at reducing the expression of the targeted mRNA in
liver compared with the parent single-stranded gapmer ASO. Toc-HDO also
improves the phenotype in disease models more effectively. In addition, the
high potency of Toc-HDO results in a reduction of liver dysfunction observed
in the parent ASO at a similar silencing effect.
Takanori Yokota, M.D., Ph.D., Professor, Neurology  Neurological Science,
Tokyo Medical and Dental University, Japan
	 2:00 	From Concept to Clinic: MRG-106, a
LNA-antimiR® Targeting microRNA-155 for 
Hematological Malignancies
microRNA-155 is a product of the bic oncogene and its overexpression has
been implicated as a poor prognostic indicator in a variety of hematological
malignancies. We identified MRG-106 through a rational screening approach
demonstrating target engagement in human cancer cells in vitro via passive
cellular uptake. Additional preclinical studies revealed a favorable PK/PD and
safety profile for the candidate. Our translational development strategy is based
on early mechanistic proof of concept and progressive de-risking in man.
William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA
	 2:30 	Oligonucleotides in Oncology and Conjugation Strategies
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Bob Brown, Ph.D., CSO and SVP, Research, Dicerna Pharmaceuticals, USA
	 3:00 	Networking Refreshment Break with Exhibit and Poster Viewing
	11:10 	Chairperson’s Remarks
El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium
	11:15 	Cystine Knot Peptides asTemplates in Drug Design
Cyclotides are ultra-stable cystine-knot containing peptides that have great
potential as templates in drug design. There are now 15 published examples
of cyclotide-based drug leads for conditions including cancer, cardiovascular
disease, autoimmune disease and pain, amongst others. This presentation will
describe the design strategies and future possibilities for cyclotide-based drug
design. Of particular note is the ability of cyclotides to penetrate cells and
modulate intracellular targets, including protein-protein interactions.
David Craik, Ph.D., Professor of Biomolecular Structure, Institute for
Molecular Bioscience University of Queensland, Australia
	11:45 	New Broad Activities of CBP501 in Tumor Cells and the
Tumor Microenvironment Uncovered by the Results of
Phase II Clinical Studies
CBP501, a synthetic dodecapeptide, completed two Phase II clinical studies
for malignant pleural mesothelioma and NSCLC. In the NSCLC study, survival
was significantly prolonged in a patient population with normal WBC. These
results led to studies revealing new broad effects of calmodulin modulation by
CBP501 in tumor cells and the tumor microenvironment. CBP501 continues to
hold promise as a drug candidate in the paradigm-shifted immune oncology
drug development world.
Takumi Kawabe, M.D., Ph.D., President  CEO, CanBas Co. Ltd., Japan
	12:15 	Networking Luncheon with Exhibit and Poster Viewing
	 1:30 	Macrocycles Addressing
ChallengingTherapeuticTargets –
An Underexploited Structural Class
Macrocycles provide diverse functionality and stereochemical complexity in a
conformationally pre-organized ring structure. This can result in high affinity
and selectivity for challenging intra- and extracellular protein targets while
preserving excellent bioavailability. Polyphor has developed two proprietary
technologies for the generation of fully synthetic macrocycles for target-
based as well as phenotypic screening. An automated and highly streamlined
medicinal chemistry optimization process to advance initial hits to clinical
candidates in rapid iterative cycles is in place. This presentation will focus on
some representative case studies.
Daniel Obrecht, Ph.D., Chief Scientific Officer, Co-Founder, Polyphor Ltd.,
Switzerland
	 2:00 	Presentation Sponsorship Opportunity
For more information about sponsoring a drug development case study,
application or technology presentation in this session, please contact
Patrick Gallagher at pgallagher@ibcusa.com
Peptide CMC and Analytical Strategies
	 2:30 	Improved Chemical and Physical Stability in Liquid
Formulations – How to Design Stable Glucagon Analogues
Through a series of iterative changes in the native sequence of glucagon
we present an optimized glucagon analogue (ZP-GA-1) suitable for
long term storage as a liquid formulation with a pharmacokinetic and
pharmacodynamic profile of native glucagon. ZP-GA-1 exhibits superior
solubility (25 mg/ml) at neutral pH relative to native glucagon and
improved chemical and physical stability.
Lise Giehm, Ph.D., Senior Scientist, Pharmaceutical Development,
Zealand Pharma A/S, Denmark
	 3:00 	Networking Refreshment Break with Exhibit and Poster Viewing
	 3:30 	CMC Challenges and Large Scale
Manufacturing of Synthetic Peptides
The latest developments in the large scale manufacturing of synthetic
peptides will be presented. The talk will consider CMC challenges, process
development and manufacturing aspects for large scale SPPS and prep.
HPLC purification.
Daniel Samson, Ph.D., Senior Director API Manufacturing, Bachem AG,
Switzerland
Oligonucleotides in Preclinical and
Clinical Development (continued)
Peptide Discovery, Preclinical and Clinical
Main Conference • Plenary Session Friday, February 26, 2016
	 6	 To Register, Call: (+65) 6508 2401  • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
	 8:45 	Registration and Coffee
	 9:10 	Chairman’s Remarks
Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo,
Japan
Keynote Presentation
	 9:15 	Challenge of Daiichi-Sankyo to be a Global
Pharma Innovator: Updated Directions
This presentation will discuss the challenge of Daiichi-
Sankyo to become one of the world’s leading innovators in
pharmaceutical drug business and RD with a diverse drug
portfolio. This talk will give an overview of Daiichi-Sankyo's
strategic business and scientific strategies, including its vision in the field of
oligonucleotide drug development.
Joji Nakayama, Representative Director, President  CEO, Daiichi Sankyo,
Japan
Featured Presentation
	 9:45 	Semaglutide, An Acylated GLP-1 Analog
Suitable for Once-Weekly Administration
Following the successful development of the first once-daily
GLP-1 analog liraglutide, we aimed to discover analogs suitable for
once-weekly dosing through acylation with fatty acids enabling
binding to serum albumin in vivo.This technology avoids the need
for substantially increased molecular weight by fusion to a large inactive protein,
or marked additives in the formulation requiring larger needle sizes.The fatty acid
“sidechain”was one of the key features to secure the combination of high albumin
affinity and high GLP-1R potency. Several parameters were investigated such as
length and type of fatty acid as well as the linking chemistry between the fatty acid
and GLP-1. Semaglutide has a peptide backbone with two substitutions compared to
human GLP-1 (8Aib, 34Arg) and is derivatized with a fatty acid“sidechain”at lysine 26.
Semaglutide is in phase 3 clinical trial for treatment of diabetes.
Jesper Lau, Ph.D., Vice President, Diabetes Protein and Peptide Chemistry,
Novo Nordisk A/S, Denmark
	10:15 	Refreshment Break
	10:45 	Late Breaking Presentation
Regulatory Perspectives on Oligonucleotide
and Peptide Impurities
	11:15 	Regulatory Considerations and Challenges on Impurity
Issues during Different Phases of Oligonucleotide and
Peptide Drug Development
Due to their diverse therapeutic activities, peptides and oligonucleotides may
be regulated under different regulations in the US, for example, as chemical
drugs or biological products, with different requirements for each. ICH changes
to the peptide guidance have also made it very challenging for companies to
deal with regulatory issues such as impurities, during the different phases of
development. The presentation will discuss 1) the effects of organization and
process changes in the US on the review and approvals of oligonucleotide and
peptide products, 2) the unique regulatory issues associated with impurities of
oligonucleotides and peptides and 3) common mistakes and how to manage
potential impurity problems during different phases of drug development, for
example, during site scale-up and site changes.
Duu-Gong Wu, Ph.D., Director/Senior Consultant, PPD Regulatory
Consulting and Former Deputy Division Director, Division of New Drug
Chemistry, US FDA/CDER, USA
	11:45 	Close of AsiaTIDES Main Conference
Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued)
Oligonucleotide CMC and Analytical Strategies
	 3:30 	CMC Case Study
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Alun Garner, Business Development Manager, Nucleic Acid Solutions
Division, Agilent Technologies, Inc.
	 4:00 	Small Scale Manufacturing of Novel Oligonucleotides
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Huihe (Julia) Zhu, Ph.D., Group Leader, Small Scale Oligo Unit,
Nitto Denko Avecia
	 4:30 	GalNac Conjugated LNA Oligonucleotides
This presentation will describe our progress with GalNac conjugated LNA
oligonucleotides. The focus of the presentation will be on CMC studies and
lessons learned, with some in-vivo data also presented.
Christoph Rosenbohm, Ph.D., Senior Director Research Operations,
Roche Innovation Center Copenhagen, Denmark
	 5:00 	Close of Day Two
	 4:00 	Life-cycle Management in Peptide Manufacturing
As technologies for the production of synthetic peptides evolve, the
chemical processes developed and validated 15 or 20 years ago often need
to be optimized for safety, productivity and cost effectiveness. As a leader in
the custom manufacturing of synthetic peptides, Lonza is putting emphasis
on the life-cycle management of its products in an increasingly competitive
environment. This case study of a generic peptide will present the activities
involved to support such a program, including process and analytical
development, process qualification and validation as well as the regulatory
filing strategy. The benefits of such a program will be described, both for the
CMO and for the customer.
Jean-Marc Poudrel, Ph.D., Program Manager, Lonza Braine SA, Belgium
	 4:30 	Development of a Large Scale Process
for the Manufacture of a Small Cyclic
Peptide API
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Jon Holbech Rasmussen, Ph.D., Director Global Development,
PolyPeptide Group, Sweden
	 5:00 	Close of Day Two
Peptide CMC and Analytical Strategies (continued)
Conference Language
The conference will be conducted in English without translation.
Travel/Visa Information
PLEASE NOTE: Visas are required for some nationalities to travel to Japan for this conference. Please
contact your travel agent and/or the Japanese Consulate/Embassy in your country for exact details
and visa application procedures as soon as possible. Visa processing times can vary.
About the Organizers
This event is brought to you by the organizers of the TIDES and EuroTIDES conferences. IBC
Life Sciences, an Informa business, is your connection to the life sciences industry. To see all
of the in-depth content IBC Life Sciences has to offer, visit www.IBCLifeSciences.com.
“AsiaTIDES was extremely productive. The senior players who attended and the intimacy of the conference afforded
many opportunities for networking with current and potential collaborators. It's a great forum if you want to further your
scientific knowledge and meet new partners. – Peter Lutwyche, Ph.D., Arbutus Biopharma Corporation
Sponsors and Exhibitors(As of October 2, 2015 , 2015)
	 Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event  	 7
Post-Conference Workshops Friday, February 26, 2016 • 12:00pm-4:00pm
Workshop #1: Current Status of Oligonucleotide
Drug Delivery Approaches and Systems (DDS)
Workshop Moderator: Dmitry Samarsky, Ph.D., SVP, International Business and
Technology Development, RiboBio, China
RNAi and antisense oligonucleotides promise to become the third major therapeutic
modality (besides small molecules and biologics), offering an opportunity to target
virtually any disease causing gene. Such promise, however, requires addressing the
challenge of delivering oligonucleotide-based therapeutic compounds to the tissues/
organs originating the disorders, as well as inside the cells producing the disease
phenotype. This workshop will dissect the delivery issue into smaller sub-challenges,
review those in deeper detail and offer some examples of successful solutions
Additional topics to be discussed include:
•Why oligos bio-distribute predominantly to a small group of organs (mostly liver)?
• If endothelial barriers prevent from broader bio-distribution, what can be done about it?
• Is tissue/organ penetration an additional challenge/barrier for oligo drug delivery?
• How do oligonucleotides cross cellular membrane barriers?
• Should we consider oligos as a class or individual compounds when it comes
to delivery?
• How big of a factor for choosing delivery approaches is the manufacturing component?
Workshop #2: Peptide Formulations:  
Regulatory Considerations for Early Clinical Research
Workshop Moderators:
Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts
Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine,
Drug Development Services, Celerion
This workshop will discuss lifecycle strategies for peptides and peptide formulations
from late stage research to early clinical development and beyond. Formulation
challenges of novel and complex peptide structures will be presented along with
dosage form strategies in early stage development and techniques for lifecycle
planning. The workshop will include a detailed case study on buccal delivery of
peptides with an emphasis on the early stage strategies needed to establish feasibility
of the project. Additional peptide case studies from early to late stage development
along with challenges encountered and lessons learned will also be presented.
Additional topics to be discussed include:
• What goes into a US Investigational New Drug (IND) application?
• What research or formulation development work is needed?
• What toxicology work is needed?
• Simple versus complex formulations and delivery options and life-cycle management
	12:00 	Networking Luncheon for Workshop Attendees
	 1:00 	Workshop Opening Remarks
	 2:30 	Refreshment Break
	 4:00 	Close of Workshop
Post-Conference
Workshop Schedule
Silver Sponsors
Agilent’s Nucleic Acid Solutions Division offers industry
leading experience to efficiently advance your lead oligo
candidates from clinic to market with a common goal of
patient health and safety. With Agilent, you always have peace of mind by partnering with a
company that has the financial resources, stability and vision required for long-term success.
Contact us at: pdl-oulderinfo@agilent.com and find out why the world’s most revolutionary
biotech companies and their Big Pharma partners are choosing Agilent Technologies to
develop and commercialize their oligo APIs.
Bachem specializes in the manufacture of peptides and
complex small molecules as APIs as well as innovative
biochemicals for research purposes. We offer technical
consultancy, comprehensive regulatory affairs support, and dedicated project management
from drug development through commercial scale cGMP production. Headquartered in
Bubendorf, Switzerland with affiliates in Europe and the U.S.
Established in 1981, ChemGenes, an ISO9001 certified
company, has consistently provided the highest quality
Phosphoramidites and Solid Supports in the market and
continues to lead the industry in oligonucleotide reagent manufacturing. Our Massachusetts
facility is setup for Bulk Therapeutic Grade phosphoramidite production for GMP grade
oligonucleotide manufacturing. Additionally, ChemGenes carries the widest variety of
modified phosphoramidites and supports currently used in oligonucleotide synthesis
including Microarray Technology, Oligonucleotide Therapeutics, Oligonucleotide Based
Probes and other areas of Nucleic Acid research. ChemGenes remains devoted to providing
you with invaluable customer service and comprehensive technical support.
Lonza offers the life sciences market a full range of bioresearch
products, development services and manufacturing for active
ingredients. For 30 years we have been helping companies increase product quality, improve
production processes, navigate regulatory hurdles, lower costs, and get to market faster.
From early development to in-market supply, our complete development services,
industry-leading manufacturing processes, broad technology platform and lifecycle
management experience can help take your product to the next level. For flexible,
high-quality manufacturing, development services and products, we can help.
Driven by Excellence, Guided by Experience. When you partner with
Avecia, (www.Avecia.com) you will be working with the leading
oligonucleotide CMO. Avecia offers the most extensive process
validation experience in the oligo industry. As a member of the Nitto
Denko Corporation (www.nitto.com), Avecia is committed to the future of the
oligonucleotide market. We offer our customers oligo manufacturing capacity in two
separate facilities (MA and OH). Our Cincinnati facility also provides expanded pre-clinical
oligo services (OliGROW), as well as small molecule expertise and production. Our aim is to
leverage our wealth of experience, to ensure we exceed our customer’s expectations. Avecia
has the stability and vision required for the long-term success of your oligo program.
The PolyPeptide Group is a leading provider of proprietary
GMP, generic and non-GMP peptides and peptide
conjugates for the pharmaceutical, cosmetic, and biotech
industries as well as basic research. With 6 GMP facilities located across 3 continents, the
Group supports peptide projects at all scales from pre-clinical through to commercialization.
Bronze Sponsors
Polyphor is a Swiss Pharma company focusing on the discovery and
development of macrocycle drugs addressing high unmet medical
needs. These macrocycles represent a new drug class
complementary to the classical small molecules and large biopharmaceuticals. Polyphor`s
proprietary technologies are broadly applicable to a wide array of biological targets and disease
areas and already delivered a rich pipeline of pre-clinical and clinical drug candidates.
Waters Division creates business advantages for laboratory-
dependent organizations by delivering ultra performance liquid
chromatography (UPLC), high performance liquid
chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry
systems, laboratory informatics solutions, and comprehensive service programs to enable
significant advancement in healthcare delivery, environmental management, food safety, and
water quality
GeneDesign specializes in contract development and
manufacturing of oligonucleotides therapeutics and
diagnostics from screening stage to commercial stage.
Session Sponsors
Networking Reception Co-Sponsors
Exhibitors(As of October 2, 2015)
Agilent Technologies Inc
Bachem AG
BCN Peptides S.A.
ChemGenes Corporation
GeneDesign Inc
Hongene Biotechnology Ltd
Kinovate Life Sciences Inc
Lonza
Nitto Avecia
Polypeptide Group
ST Pharm
Connect with 200+ Oligo and Peptide Decision Makers
Reserve Your Exhibit Booth or Sponsorship Today!
• Showcase your latest technology to our targeted audience of key decision-makers
• Build invaluable relationships and form new partnerships that give you a
competitive advantage in the US, Europe and Asia-Pacific
• Gain international exposure through our specialized marketing campaign
Call today to learn about the cost effective ways to drive lead generation and
network with key buyers, including: Turn Key Exhibit Booth Packages, Event
Partner Packages; Spotlight Session and Luncheon Briefing Sponsorships;
Custom Emails, and Meeting Space
For more information on how you can connect with these key
buyers, contact: Patrick Gallagher • Tel: 617-512-6656
Email: pgallagher@ibcusa.com
Payment
Payment must be received 10 business days prior to the event.
To take advantage of discounts with an expiry cut-off date,
registration and payment must be received by the cut-off date.
• Payments by USD bank draft or cheque should be made
in favour of “IBC Asia (S) Pte Ltd” and mailed to:
IBC Asia (S) Pte Ltd
c/o Informa Regional Business Services
111 Somerset Road, TripleOne Somerset #10-06,
Singapore 238164
Attn: The Accounts Receivable Team
• Payment by telegraphic transfer in USD must be made to:
IBC Asia (S) Pte Ltd
A/C No.: 260-457866-178 (USD)
The Hongkong and Shanghai Banking Corporation Limited,
21Collyer Quay, HSBC Building, Singapore 049320
Bank Swift Code: HSBCSGSG
Bank Code: 7232
• Payment by Credit Card (AMEX, VISA or MASTERCARD)
Please provide your Card Number, Name of Cardholder, Expiry
Date and Signature and send it by fax to +65 6508 2407.
Important Note
Please quote the name of the delegate, event title and
invoice number on the advice when remitting payment.
Bank charges are to be deducted from participating
organisations’ own accounts. Please fax your payment
details (copy of remittance advice, cheque or draft to +65
6508 2407).
Attendance will only be permitted upon receipt of full
payment. Participants wishing to register at the door
are responsible to ensure all details are as published.
IBC assumes no further liability or obligation, beyond
the refund of the paid registration fee, in the event of
postponement or cancellation by IBC.
Registration Substitutions/Cancellations
Should you be unable to attend, a substitute delegate
is welcome at no extra charge. Cancellations must be
received in writing at least 10 business days before the start
of the event, to receive a refund less 10% processing fee
per registration.The company regrets that no refund will
be made available for cancellation notifications received
less than 10 business days before the event. IBC reserves
the right to cancel or alter the content and timing of the
program for reasons beyond its control and will NOT be
held accountable for any costs incurred by the participants.
Speakers are subject to change without prior notification.
Data Protection
The personal information entered during your registration/
order, or provided by you, will be held on a database and
may be shared with companies in the Informa Group in
the UK and internationally. Occasionally, your details may
be obtained from or shared with external companies
who wish to communicate with you offers related to
your business activities. If you do not wish your details
to be used for this purpose, please contact our Database
Department at Email: database@ibcasia.com.sg, Tel: +65
6508 2400 or Fax: +65 6508 2408.
Please tick: o I enclose my Cheque/Draft payable to IBC Asia (S) Pte Ltd
o I am paying by bank transfer (copy attached)
o Payment by Credit Card: o Amex o Visa o Mastercard
Credit Card Payments: The best way to pay by credit card is through our secure on-line registration process, simply log on to the
website at www.IBCLIfeSciences.com/AsiaTIDES and click “Register Now”. If you would prefer to pay over the phone please complete
the contact name and details and someone from our Customer Services Team will call within 24 hours to take payment. As we treat your
credit card information in the strictest confidence, please do not send payment details by email.
Credit Card Contact:______________________________________ 	Department:_________________________________________
Direct phone number:____________________________________ 	Email:________________________________________________
Name: Dr/Mr/Ms_______________________________________ 	E-Mail______________________________________________
Job Title____________________________________________ 	 Mobile no____________________________________________
Department__________________________________________ 	Company____________________________________________
Address_____________________________________________ 	 Post Code____________________________________________
Tel________________________________________________ 	 Main Business/Activity____________________________________
Name  Title of Approving Manager____________________________ 	 Name  Title of Training Manager_____________________________
Industry Rates SAVE USD400
by Nov. 20, 2015
SAVE USD300
by Dec. 18, 2015
SAVE USD200
by Jan. 15, 2016
SAVE USD100
by Feb. 5, 2016
Standard Rate
After Feb. 5, 2016
o Main Conference + Workshop* USD 1,899 USD 1,999 USD 2,099 USD 2,199 USD 2,299
o Main Conference Only USD 1,599 USD 1,699 USD 1,799 USD 1,899 USD 1,999
Group Rates (3+ from same company)
SAVE USD400
by Nov. 20, 2015
SAVE USD300
by Dec. 18, 2015
SAVE USD200
by Jan. 15, 2016
SAVE USD100
by Feb. 5, 2016
Standard Rate
After Feb. 5, 2016
o Main Conference + Workshop* USD 1,699 USD 1,799 USD 1,899 USD 1,999 USD 2,099
o Main Conference Only USD 1,399 USD 1,499 USD 1,599 USD 1,699 USD 1,799
*Select one Post-Conference Workshop: 
o Workshop #1: Current Status of Oligonucleotide Drug Delivery Approaches and Systems (DDS)
o Workshop #2: Peptide Formulations:  Regulatory Considerations for Early Clinical Research
Academia/Government Discounts – 40% Savings: Academic and government employees are eligible for over 40%
savings compared to the industry fees. Rate extended to full-time employees of government, universities and university-
affiliated hospitals who have NO affiliation to a for profit entity. See website for details.
Present a Poster o USD125 - Commercial o FREE - Academic
o Attend Networking Dinner (Tuesday, February 24, 2016 • 6:45pm) USD120
Please tell us your primary area of interest: o Oligonucleotides o Peptides
Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for
the same event, at the same time. Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early
bird rate OR special rate OR group rate. All fees stated include luncheons, refreshments and complete set of documentation. It
does not include the cost of accommodation and travel. Registration fees are subject to the prevailing government tax.
If undelivered, please return to:
111 Somerset Road
TripleOne Somerset #10-06, Singapore 238164
Tel: +65 6508 2400  Fax:  + 65 6508 2408
RESERVE YOUR PLACE TODAY!
This label contains your priority booking code. To expedite registration, please do not remove label. If you have already
received a copy of this brochure, we apologise. For reasons of confidentiality, your full particulars were not available to IBC
Asia (S) Pte Ltd for deduplication prior to mail drop.
SaveUpToUSD400
withtheEarlyBirdRates!
Groups of 3+ Save an
Additional USD200 per person.
See below for details!
AsiaTIDES – Oligonucleotide and Peptide® Research, Technology and Product Development
P46303
REGISTER NOW! FAX BACKTO (65) 6508 2407 OR EMAILTO REGISTER@IBCASIA.COM.SG
EASIEST: www.IBCLifeSciences.com/AsiaTIDES
CALL
+65 6508 2401
EMAIL
register@ibcasia.com.sg
5 WAYS TO REGISTER
FAX
+ 65 6508 2407
IBC Asia (S) Pte Ltd
c/o Informa Regional Business Services
111 Somerset Road,
TripleOne Somerset #10-06,
Singapore 238164
MAILthe attached registration
form with your cheque to
Priority Code: R16225pdfwdl

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8th Asia Tides Feb 2016, Kyoto, Japan

  • 1. IBC’s 8th Annual Register Early and Save Up to USD400! www.IBCLifeSciences.com/AsiaTIDES February 24-26, 2016 • Westin Miyako Kyoto • Kyoto, Japan The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss current strategies and trends to accelerate promising molecules from research to commercialization 世界中のオリゴヌクレオチドとペプチドのグローバルリーダー達が一堂に会するアジア唯一のイベン トで、前途有望な分子の研究から商業化までを加速するために、現在の戦略と傾向を話し合います。 Duchenne Muscular Dystrophy Once-Weekly Peptide: Semaglutide Challenge to be a Global Pharma Innovator Exon-skipping Therapies Constrained Peptides and Peptide-Based Drug Design Locked Nucleic Acids Global Experts Help Accelerate Your Molecules to Market Joji Nakayama Daiichi Sankyo, Japan Masafumi Matsuo, M.D., Ph.D. Kobe Gakuin University, Japan Keiichi Masuya, Ph.D. PeptiDream Inc., Japan Troels Koch, Ph.D. Roche Innovation Center Copenhagen, Denmark Shin'ichiTakeda, M.D., Ph.D. National Center of Neurology and Psychiatry, Japan Jesper Lau, Ph.D. Novo Nordisk A/S, Denmark Media Parters: Organized by: n Optimize the drug-like properties of your molecule for accelerated approval • Phase 2/3 case studies • Delivery/formulation • Conjugates • Novel discoveries n Discover CMC techniques and analytical strategies for complex molecules • Large & small scale • Cost reduction • Novel synthesis • Lifecycle management n Reach new markets & find partners for your molecules, technologies and services •Innovation & investment landscape • Regulatory perspectives • Networking dinner
  • 2. Dear Colleagues: AsiaTIDES is Asia-Pacific’s leading oligonucleotide and peptide therapeutics event for discovery, clinical and CMC scientists to share best practices and success factors to help you accelerate molecules from research to commercialization. The international speaker faculty represents companies from the US, Europe, Japan, Australia and APAC and provides a comprehensive update on the global progress of oligonucleotides and peptides in development, so you can benchmark your own programs and find new ideas to improve the development of your products. In response to your requests, this year’s program includes more preclinical and clinical case studies than ever before from industry bellwether companies including: • Isis Pharmaceuticals • Alnylam • Novo Nordisk • Roche • Daiichi Sankyo • Polyphor • Sarepta Therapeutics • CanBas • Dicerna • PeptiDream • Noxxon • miRagen Therapeutics • Zealand Pharma • and many more…. I encourage you to register today and maximize the value of attending AsiaTIDES in Kyoto by participating in these additional activities: • Share and find new research in the poster sessions • Evaluate new products and services in the exhibit hall • Find collaborators during the networking breaks, lunches, networking dinner and cocktails • Take an extra day to explore the historic and beautiful city of Kyoto Sincerely, Michael P. Keenan Project Manager and Producer Your International AsiaTIDES Advisory Committee Robert Hagopian, Director Business Development, PolyPeptide Laboratories, USA Yusuke Kohno, Vice President, Jitsubo Co Limited, Japan Shawn Lee, Ph.D., President and CEO, CPC Scientific, USA and China Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and CEO Founder, OliX Pharmaceuticals, Korea Patrick Lu, Ph.D., Founder, President and CEO, Sirnaomics, Inc., USA Michael McGinley, Manager, Core Products, Phenomenex, USA Bruce Morimoto, Ph.D., Executive Director Applied Translational, Medicine, Drug Development Services, Celerion, USA El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium Hideaki Sato, General Manager, Technical Support and Marketing, GeneDesign, Inc., Japan Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo, Japan Dmitry Samarsky, Ph.D., SVP, International Business and Technology Development, RiboBio, China G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA Daisuke Takahashi, Ph.D., Manager, Bio-functional Molecular Chemistry Group, Research Institute for Bioscience Products Fine Chemicals, Ajinomoto Co., Inc., Japan 2 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg Accelerate Your Oligo and Peptide Molecules to Market Meet the People Behind the Products and Get the AnswersYou Need The AsiaTIDES Exhibit Hall will give you the opportunity to find the technologies and services you need to accelerate research, discovery efforts and clinical programs. Visit vendor booths to discuss new product advancements, network with industry and academic researchers, engineers and executives during scheduled luncheons and receptions, or spend time at the popular and innovative Poster Sessions. See more details on page 7. Call for Posters Limited space is available for poster presentations at this event. If you have new results/data on topics relevant to this conference, we encourage you to submit a poster abstract for consideration. To present a poster, complete the conference registration form and submit poster title and one page poster abstract online at www.IBCLifeSciences.com/AsiaTIDES by January 27, 2016. See registration form for poster fees. The Westin Miyako Kyoto 1 Awataguchi Kachocho, Higashiyama-ku, Kyoto 605-0052, Japan Tel: +81-75-771-7111 • Fax: +81-75-751-2490 Website: http://www.miyakohotels.ne.jp/westinkyoto/english/index.html/ Special Room Rates for AsiaTIDES Attendees: JPY 19440/JPY 21600 (Superior Single/Twin) •JPY 25960/JPY 28080 (Deluxe Single/Twin) To book a room at the Westin Miyako Hotel at the special AsiaTIDES group rate, please reserve your room by visiting the hotel section at www.IBCLifeSciences.com/AsiaTIDES
  • 3. Main Conference • Concurrent Tracks Wednesday, February 24, 2016 Oligonucleotides in Preclinical and Clinical Development 11:00 Chairman’s Remarks Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA 11:15 Stabilization and Activation of Double-stranded Nucleic Acid Drugs by Artificial Cationic Molecules We have developed novel cationic oligosaccharides and cationic peptides that selectively bind to A-type RNA/RNA and DNA/RNA duplexes. In this presentation, I would like to describe the synthesis and properties of these unique molecules as carriers and stabilizers of siRNA drugs and antisense DNA/RNA heteroduplexes. Takeshi Wada, Ph.D., Professor, Department of Medicinal and Life Science, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Japan 11:45 Defining the Relationship between ASGR Binding and Activity for GalNAc-ASO Conjugates A fluorescence polarization competition assay was established to determine the influence of GalNAc valency, ASO length, backbone composition and charge on ASGR binding. Results gained from this approach were correlated to ASO activity in hepatocytes and mice. Our work provides insights into the interactions of ASO-conjugates with cell-surface receptors and on functional uptake of ASOs into cells and tissues. Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA 12:15 Networking Luncheon with Exhibit and Poster Viewing 1:30 Presentation Sponsorship Opportunity For more information about sponsoring a drug development case study, application or technology presentation in this session, please contact Patrick Gallagher at pgallagher@ibcusa.com. 2:00 PreclinicalTherapeutic Development againstTopical Diseases Using Cell Penetrating, Asymmetric RNAiTriggers Cell penetrating, asymmetric siRNA (cp-asiRNA) is an asymmetric RNAi trigger with simple combination of chemical modifications. cp-asiRNA enters into cells and triggers target gene silencing via RNA interference without the need of delivery vehicle. Preclinical therapeutic development against skin, eye and lung diseases using cp-asiRNA platform will be presented. Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and Founder and CEO, OliX Pharmaceuticals, Korea Featured Presentation 2:30 Activity Determinants of Locked Nucleic Acids Small structural modifications of antisense oligonucleotides can have significant effects on structure/activity relations. The underlying nature of these subtle relationships cannot be understood from a reductionist view point. We have employed a new modelling strategy to get a better understanding on how the structural units can impact the properties of LNA. It will be presented how new chemical modifications and designs can improve central therapeutic parameters of LNA. Troels Koch, Ph.D., VP Head of Research, RNA Therapeutics, Roche Innovation Center Copenhagen, Denmark 3:00 Networking Refreshment Break with Exhibit and Poster Viewing Peptide Discovery 11:00 Chairman’s Remarks Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine, Drug Development Services, Celerion, USA 11:15 Oral Equivalents of Monoclonal Antibodies: Exploitation of Constrained Peptides This presentation will briefly describe platform technology and focus on optimization of the oral delivery of constrained peptides, that are alternatives to marketed antibodies Stelara and Entyvio, for treatment of IBD. The presentation will describe rodent and monkey data, and criteria for selection of IND candidates which should enter the clinic in 2015 and early 2016. Mark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics, Australia 11:45 Presentation Title TBA Abstract not available at time of print. Please visit www.IBCLifeSciences.com/AsiaTIDES for updates. Speaker TBA, Waters 12:15 Networking Luncheon with Exhibit and Poster Viewing Drug Delivery Strategies for Peptides 1:30 Delivery Strategies for Peptides in Clinical Development This presentation will include a brief overview of technologies available for subcutaneous injection replacement, injectable sustained release formulation, half-life extension and non-invasive delivery. The challenges and opportunities for each of these approaches will be clarified. In addition, a pathway for clinical development of a new peptide will be discussed along with strategy and timing for incorporating life cycle options. Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts, USA 2:00 Peptide Mediated Delivery of Bioactive Proteins into Cells Numerous approaches have been reported up to the present time for intracellular delivery. However, approaches are still needed that have improved efficacy in delivering high-molecular-weight proteins into cytosol to obtain enhanced bioactivity. By modifying sequences of natural hemolytic peptides, we have succeeded in creating a peptide, which has a low cytotoxicity but has a high ability to yield a marked cytosolic release of endocytosed proteins. Shiroh Futaki, Ph.D., Professor, Institute for Chemical Research, Kyoto University, Japan 2:30 Biodegradable Silica Based Delivery of Therapeutic Peptides Biodegradable silica is a powerful drug delivery matrix for sustained release of parenteral therapeutics. Encapsulation of peptides in nanoporous silica provides an effective tool to administer peptides in a controlled manner even for several months. The presentation describes the basics of silica technology with several case studies. Lasse Leino, Ph.D., Adjunct Professor and CEO, DelSiTech Ltd., Finland 3:00 Networking Refreshment Break with Exhibit and Poster Viewing Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 3 Main Conference • Plenary Session Wednesday, February 24, 2016 Keynote Presentation 9:15 Therapeutic Approaches to Duchenne Muscular Dystrophy Duchenne muscular dystrophy (DMD) is the most common childhood genetic disease, affecting one in 3,500 newborn boys, causing progressive muscle weakness, heart and respiratory failure and premature death. This disease is caused by the mutations of the DMD gene, and no cure exists for this disease, but a number of promising new molecular therapies are being intensively studied. Among them, exon skipping by antisense oligonucleotides is a novel method to restore the reading frame of the mutated DMD gene, and rescue dystrophin expression. I will present the recent progress of therapy of the disease. Shin'ichi Takeda, M.D., Ph.D., Director General, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Japan Keynote Presentation 9:45 Paradigm Shift in Drug Discovery: Constrained Peptides and Peptide-Based Drug Design Constrained peptides represent highly valuable chemical matter for use in biological validation, identifying hit/lead molecules for drug discovery, and also directly as peptide therapeutics. Our in-house approach to the optimization of constrained peptides, and how these peptides contribute to hit finding for difficult target classes from a general perspective will be introduced. Keiichi Masuya, Ph.D., Chief Operating Officer, PeptiDream, Inc., Japan 8:15 Registration and Coffee 9:10 Chairman’s Remarks Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia 10:15 Networking Refreshment Break with Exhibit and Poster Viewing
  • 4. Main Conference • Concurrent Tracks Wednesday, February 24, 2016(continued) 4 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg 3:45 Daiichi-Sankyo’s Strategies and Experiences in Biologics focused Oligonucleotide Drug Development This presentation will discuss Daiichi-Sankyo’s progress in the development of biologics especially oligonucleotide drugs. Lessons learned to date, technical challenges experienced and future approaches to progress our oligonucleotides drugs as an important part of our biologics pipeline will be presented. Junichi Koga, Ph.D., Corporate Officer and Global Head of Biologics, Daiichi Sankyo, Japan 4:15 ALN-HBV, An Investigational RNAi Drug for the Treatment of Chronic Hepatitis B Chronic hepatitis B infection is a serious liver disease impacting 400 million people worldwide. Clinical manifestations are severe, and an estimated 1 million people die each year from the disease and its complications. With today’s medicines, the cure rate for chronic HBV infection is less than 10%. An RNAi therapeutic inhibiting all steps of the HBV life cycle and silencing tolerogenic viral antigens has the potential to achieve a“functional cure.” Laura Sepp-Lorenzino, Ph.D., Vice President, Entrepreneur-in-Residence, Alnylam Pharmaceuticals, USA 4:45 Eteplirsen a Drug for Duchenne Muscular Dystrophy DMD, a neuromuscular disease, affects ~1:3500 of newborn boys and invariably leads to their untimely death. DMD is most commonly caused by deletions in the DMD gene that disrupt the mRNA reading frame and prevent translation of dystrophin, an essential muscle protein. In ongoing trials, eteplirsen, a morpholino oligomer, has been shown to restore the mRNA reading frame and induce production of dystrophin. This treatment led to significant benefit in the six-minute walk test. Ryszard Kole, Ph.D., Distinguished Scientist, Sarepta Therapeutics, USA 3:45 Phylomer Derived Cell Penetrating Peptides Facilitate More Efficient Delivery of Peptides and Proteins to the Cytoplasm Phylomer peptide libraries have been screened for new cell penetrating peptides for delivery of macromolecules and nanoparticles into cells. A novel genetic screen known as the‘endosome escape trap’enables the isolation of rare CPP’s which more efficiently deliver their cargoes to the cytoplasm. Some of these cell penetrating Phylomers can be targeted to particular cell types. Phylogica has developed a variety of functional assays to determine the extent of cytoplasmic delivery of peptide and protein cargoes to the cytoplasm or nucleus. These assays have shown Phylomer CPP’s to be 37-160 times more efficient than TAT which can be active in vivo. These tools are now being applied in screens targeting transcription factor oncoproteins such as cMyc NMyc and STAT5 as well as for more efficient intracellular delivery of protein toxin conjugates. Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia 4:15 An Improved Transdermal Patch of Teriparatide Using Ionic Liquid Transdermal System (ILTS) Teriparatide is a recombinant parathyroid hormone used in the treatment of osteoporosis and approved as a subcutaneous injection. A transdermal patch which delivers teriparatide is being developed using Ionic Liquid Technology. A series of in vitro rat skin permeation tests and in vivo rat PK studies have been conducted which led to selection of a formulation which demonstrated a temporary increase in the concentration of teriparatide in the blood. Additionally, dermal irritation tests confirmed that there was no dermal irritation to the rat skin. Tatsuro Moriyoshi, Researcher, RD Department, MEDRx Co. Ltd., Japan Panel Discussion 4:45 Drug Delivery Systems and Strategies Moderator: Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine, Drug Development Services, Celerion, USA 5:15 Networking Reception in Exhibit and Poster Hall Co-sponsored by: and Main Conference • Plenary Session Thursday, February 25, 2016 8:30 Registration and Coffee 8:55 Chairman’s Remarks William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA The Innovation and Investment Landscape in Japan and China 9:00 The Japan Landscape of Investment and Innovation in Oligonucleotide and Peptide Development INCJ is a public-private investment fund which provides financial and management support for next-generation businesses including innovative drug development. This presentation will provide an overview of the investment and innovation landscape in Japan as well as discuss the future potential of and opportunities in oligonucleotide and peptide drug development in Japan. Koichi Ashida, Executive Managing Director, Innovation Network of Japan, Japan 9:30 Development and Production of Therapeutic Oligonucleotides in China There is a growing interest towards oligonucleotide-based therapeutics among drug developers in China. The field, however, still remains at relatively early stages. This presentation will summarize current status of oligonucleotide therapeutic programs. It will also outline the situation with the oligonucleotide manufacturing capabilities in China. Finally, a summary of the recently introduced by CFDA changes to the overall drug development process and procedures in the country will be presented. Dmitry Samarsky, Ph.D., SVP, International Business and Technology Development, RiboBio, China Keynote Presentation 10:00 Exon-skipping Therapy Advancing Oligonucleotide Drug Development This presentation will describe continued efforts in our laboratory to exploit exon-skipping oligonucleotides to treat a variety of diseases. Current progress and ongoing challenges of exon- skipping will be discussed. An update on the learnings from clinical studies in DMD patients will also be presented. Masafumi Matsuo, M.D., Ph.D., Professor, Department of Medical Rehabilitation, Kobe Gakuin University, Japan 10:30 Networking Refreshment Break with Exhibit and Poster Viewing Oligonucleotides in Preclinical and Clinical Development (continued) Drug Delivery Strategies for Peptides (continued) 6:45 Networking Dinner in Kyoto Join fellow attendees in a fantastic networking and dining opportunity at a local restaurant in beautiful Kyoto. Space is limited and an additional fee applies. Please indicate when you register if you plan to join the dinner.
  • 5. Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 5 Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued) 11:10 Chairperson’s Remarks Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG, Germany 11:15 Clinical Efficacy of AZD9150, a Next Generation, Constrained Ethyl Modified Antisense Oligonucleotide Inhibitor of STAT3 – Tumor Cell Autonomous and Immuno-modulatory Activity AZD9150 is a next generation ASO that has demonstrated robust single agent efficacy in several tumor types in phase I clinical studies. Preclinical and clinical data suggest the activity of AZD9150 is mediated by both tumor cell autonomous effects as well as through modulation of the immunosuppressive microenvironment through the inhibition of STAT3 in tumor-associated immune cell populations. A.Robert MacLeod, Ph.D., Vice President Oncology and Exploratory Discovery, Isis Pharmaceuticals, USA 11:45 Mirror-image Oligonucleotide Aptamers Inhibiting the Chemokine CXCL12/SDF-1 - From Identification to Phase IIa Data SDF-1/CXCL12 is a pro-angiogenic chemokine that plays a major role in homing processes of stem cells and malignant stem cells. Furthermore, the chemokine also interacts with two receptors, i.e. CXCR4 and CXCR7. We have identified a high affinity mirror-image oligonucleotide (NOX-A12, olaptesed pegol) that neutralizes SDF-1's interactions with both receptors. The compounds showed intriguing efficacy in different oncology models. Currently, the substance is profiled in two Phase IIa studies in patients with multiple myeloma and chronic lymphocytic leukemia. Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG, Germany 12:15 Networking Luncheon with Exhibit and Poster Viewing 1:30 DNA/RNA Heteroduplex Oligonucleotide as a Novel Concept of Therapeutic Oligonucleotide We develop a short DNA/RNA heteroduplex oligonucleotide (HDO) with a structure different from double-stranded RNA used for short interfering RNA and single-stranded DNA used for ASO. A DNA/lockednucleotide acid gapmer duplex with an a-tocopherol-conjugated complementary RNA (Toc-HDO) is significantly more potent at reducing the expression of the targeted mRNA in liver compared with the parent single-stranded gapmer ASO. Toc-HDO also improves the phenotype in disease models more effectively. In addition, the high potency of Toc-HDO results in a reduction of liver dysfunction observed in the parent ASO at a similar silencing effect. Takanori Yokota, M.D., Ph.D., Professor, Neurology Neurological Science, Tokyo Medical and Dental University, Japan 2:00 From Concept to Clinic: MRG-106, a LNA-antimiR® Targeting microRNA-155 for Hematological Malignancies microRNA-155 is a product of the bic oncogene and its overexpression has been implicated as a poor prognostic indicator in a variety of hematological malignancies. We identified MRG-106 through a rational screening approach demonstrating target engagement in human cancer cells in vitro via passive cellular uptake. Additional preclinical studies revealed a favorable PK/PD and safety profile for the candidate. Our translational development strategy is based on early mechanistic proof of concept and progressive de-risking in man. William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA 2:30 Oligonucleotides in Oncology and Conjugation Strategies Abstract not available at time of print. Please visit www.IBCLifeSciences.com/AsiaTIDES for updates. Bob Brown, Ph.D., CSO and SVP, Research, Dicerna Pharmaceuticals, USA 3:00 Networking Refreshment Break with Exhibit and Poster Viewing 11:10 Chairperson’s Remarks El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium 11:15 Cystine Knot Peptides asTemplates in Drug Design Cyclotides are ultra-stable cystine-knot containing peptides that have great potential as templates in drug design. There are now 15 published examples of cyclotide-based drug leads for conditions including cancer, cardiovascular disease, autoimmune disease and pain, amongst others. This presentation will describe the design strategies and future possibilities for cyclotide-based drug design. Of particular note is the ability of cyclotides to penetrate cells and modulate intracellular targets, including protein-protein interactions. David Craik, Ph.D., Professor of Biomolecular Structure, Institute for Molecular Bioscience University of Queensland, Australia 11:45 New Broad Activities of CBP501 in Tumor Cells and the Tumor Microenvironment Uncovered by the Results of Phase II Clinical Studies CBP501, a synthetic dodecapeptide, completed two Phase II clinical studies for malignant pleural mesothelioma and NSCLC. In the NSCLC study, survival was significantly prolonged in a patient population with normal WBC. These results led to studies revealing new broad effects of calmodulin modulation by CBP501 in tumor cells and the tumor microenvironment. CBP501 continues to hold promise as a drug candidate in the paradigm-shifted immune oncology drug development world. Takumi Kawabe, M.D., Ph.D., President CEO, CanBas Co. Ltd., Japan 12:15 Networking Luncheon with Exhibit and Poster Viewing 1:30 Macrocycles Addressing ChallengingTherapeuticTargets – An Underexploited Structural Class Macrocycles provide diverse functionality and stereochemical complexity in a conformationally pre-organized ring structure. This can result in high affinity and selectivity for challenging intra- and extracellular protein targets while preserving excellent bioavailability. Polyphor has developed two proprietary technologies for the generation of fully synthetic macrocycles for target- based as well as phenotypic screening. An automated and highly streamlined medicinal chemistry optimization process to advance initial hits to clinical candidates in rapid iterative cycles is in place. This presentation will focus on some representative case studies. Daniel Obrecht, Ph.D., Chief Scientific Officer, Co-Founder, Polyphor Ltd., Switzerland 2:00 Presentation Sponsorship Opportunity For more information about sponsoring a drug development case study, application or technology presentation in this session, please contact Patrick Gallagher at pgallagher@ibcusa.com Peptide CMC and Analytical Strategies 2:30 Improved Chemical and Physical Stability in Liquid Formulations – How to Design Stable Glucagon Analogues Through a series of iterative changes in the native sequence of glucagon we present an optimized glucagon analogue (ZP-GA-1) suitable for long term storage as a liquid formulation with a pharmacokinetic and pharmacodynamic profile of native glucagon. ZP-GA-1 exhibits superior solubility (25 mg/ml) at neutral pH relative to native glucagon and improved chemical and physical stability. Lise Giehm, Ph.D., Senior Scientist, Pharmaceutical Development, Zealand Pharma A/S, Denmark 3:00 Networking Refreshment Break with Exhibit and Poster Viewing 3:30 CMC Challenges and Large Scale Manufacturing of Synthetic Peptides The latest developments in the large scale manufacturing of synthetic peptides will be presented. The talk will consider CMC challenges, process development and manufacturing aspects for large scale SPPS and prep. HPLC purification. Daniel Samson, Ph.D., Senior Director API Manufacturing, Bachem AG, Switzerland Oligonucleotides in Preclinical and Clinical Development (continued) Peptide Discovery, Preclinical and Clinical
  • 6. Main Conference • Plenary Session Friday, February 26, 2016 6 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg 8:45 Registration and Coffee 9:10 Chairman’s Remarks Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo, Japan Keynote Presentation 9:15 Challenge of Daiichi-Sankyo to be a Global Pharma Innovator: Updated Directions This presentation will discuss the challenge of Daiichi- Sankyo to become one of the world’s leading innovators in pharmaceutical drug business and RD with a diverse drug portfolio. This talk will give an overview of Daiichi-Sankyo's strategic business and scientific strategies, including its vision in the field of oligonucleotide drug development. Joji Nakayama, Representative Director, President CEO, Daiichi Sankyo, Japan Featured Presentation 9:45 Semaglutide, An Acylated GLP-1 Analog Suitable for Once-Weekly Administration Following the successful development of the first once-daily GLP-1 analog liraglutide, we aimed to discover analogs suitable for once-weekly dosing through acylation with fatty acids enabling binding to serum albumin in vivo.This technology avoids the need for substantially increased molecular weight by fusion to a large inactive protein, or marked additives in the formulation requiring larger needle sizes.The fatty acid “sidechain”was one of the key features to secure the combination of high albumin affinity and high GLP-1R potency. Several parameters were investigated such as length and type of fatty acid as well as the linking chemistry between the fatty acid and GLP-1. Semaglutide has a peptide backbone with two substitutions compared to human GLP-1 (8Aib, 34Arg) and is derivatized with a fatty acid“sidechain”at lysine 26. Semaglutide is in phase 3 clinical trial for treatment of diabetes. Jesper Lau, Ph.D., Vice President, Diabetes Protein and Peptide Chemistry, Novo Nordisk A/S, Denmark 10:15 Refreshment Break 10:45 Late Breaking Presentation Regulatory Perspectives on Oligonucleotide and Peptide Impurities 11:15 Regulatory Considerations and Challenges on Impurity Issues during Different Phases of Oligonucleotide and Peptide Drug Development Due to their diverse therapeutic activities, peptides and oligonucleotides may be regulated under different regulations in the US, for example, as chemical drugs or biological products, with different requirements for each. ICH changes to the peptide guidance have also made it very challenging for companies to deal with regulatory issues such as impurities, during the different phases of development. The presentation will discuss 1) the effects of organization and process changes in the US on the review and approvals of oligonucleotide and peptide products, 2) the unique regulatory issues associated with impurities of oligonucleotides and peptides and 3) common mistakes and how to manage potential impurity problems during different phases of drug development, for example, during site scale-up and site changes. Duu-Gong Wu, Ph.D., Director/Senior Consultant, PPD Regulatory Consulting and Former Deputy Division Director, Division of New Drug Chemistry, US FDA/CDER, USA 11:45 Close of AsiaTIDES Main Conference Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued) Oligonucleotide CMC and Analytical Strategies 3:30 CMC Case Study Abstract not available at time of print. Please visit www.IBCLifeSciences.com/AsiaTIDES for updates. Alun Garner, Business Development Manager, Nucleic Acid Solutions Division, Agilent Technologies, Inc. 4:00 Small Scale Manufacturing of Novel Oligonucleotides Abstract not available at time of print. Please visit www.IBCLifeSciences.com/AsiaTIDES for updates. Huihe (Julia) Zhu, Ph.D., Group Leader, Small Scale Oligo Unit, Nitto Denko Avecia 4:30 GalNac Conjugated LNA Oligonucleotides This presentation will describe our progress with GalNac conjugated LNA oligonucleotides. The focus of the presentation will be on CMC studies and lessons learned, with some in-vivo data also presented. Christoph Rosenbohm, Ph.D., Senior Director Research Operations, Roche Innovation Center Copenhagen, Denmark 5:00 Close of Day Two 4:00 Life-cycle Management in Peptide Manufacturing As technologies for the production of synthetic peptides evolve, the chemical processes developed and validated 15 or 20 years ago often need to be optimized for safety, productivity and cost effectiveness. As a leader in the custom manufacturing of synthetic peptides, Lonza is putting emphasis on the life-cycle management of its products in an increasingly competitive environment. This case study of a generic peptide will present the activities involved to support such a program, including process and analytical development, process qualification and validation as well as the regulatory filing strategy. The benefits of such a program will be described, both for the CMO and for the customer. Jean-Marc Poudrel, Ph.D., Program Manager, Lonza Braine SA, Belgium 4:30 Development of a Large Scale Process for the Manufacture of a Small Cyclic Peptide API Abstract not available at time of print. Please visit www.IBCLifeSciences.com/AsiaTIDES for updates. Jon Holbech Rasmussen, Ph.D., Director Global Development, PolyPeptide Group, Sweden 5:00 Close of Day Two Peptide CMC and Analytical Strategies (continued) Conference Language The conference will be conducted in English without translation. Travel/Visa Information PLEASE NOTE: Visas are required for some nationalities to travel to Japan for this conference. Please contact your travel agent and/or the Japanese Consulate/Embassy in your country for exact details and visa application procedures as soon as possible. Visa processing times can vary. About the Organizers This event is brought to you by the organizers of the TIDES and EuroTIDES conferences. IBC Life Sciences, an Informa business, is your connection to the life sciences industry. To see all of the in-depth content IBC Life Sciences has to offer, visit www.IBCLifeSciences.com. “AsiaTIDES was extremely productive. The senior players who attended and the intimacy of the conference afforded many opportunities for networking with current and potential collaborators. It's a great forum if you want to further your scientific knowledge and meet new partners. – Peter Lutwyche, Ph.D., Arbutus Biopharma Corporation
  • 7. Sponsors and Exhibitors(As of October 2, 2015 , 2015) Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 7 Post-Conference Workshops Friday, February 26, 2016 • 12:00pm-4:00pm Workshop #1: Current Status of Oligonucleotide Drug Delivery Approaches and Systems (DDS) Workshop Moderator: Dmitry Samarsky, Ph.D., SVP, International Business and Technology Development, RiboBio, China RNAi and antisense oligonucleotides promise to become the third major therapeutic modality (besides small molecules and biologics), offering an opportunity to target virtually any disease causing gene. Such promise, however, requires addressing the challenge of delivering oligonucleotide-based therapeutic compounds to the tissues/ organs originating the disorders, as well as inside the cells producing the disease phenotype. This workshop will dissect the delivery issue into smaller sub-challenges, review those in deeper detail and offer some examples of successful solutions Additional topics to be discussed include: •Why oligos bio-distribute predominantly to a small group of organs (mostly liver)? • If endothelial barriers prevent from broader bio-distribution, what can be done about it? • Is tissue/organ penetration an additional challenge/barrier for oligo drug delivery? • How do oligonucleotides cross cellular membrane barriers? • Should we consider oligos as a class or individual compounds when it comes to delivery? • How big of a factor for choosing delivery approaches is the manufacturing component? Workshop #2: Peptide Formulations: Regulatory Considerations for Early Clinical Research Workshop Moderators: Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine, Drug Development Services, Celerion This workshop will discuss lifecycle strategies for peptides and peptide formulations from late stage research to early clinical development and beyond. Formulation challenges of novel and complex peptide structures will be presented along with dosage form strategies in early stage development and techniques for lifecycle planning. The workshop will include a detailed case study on buccal delivery of peptides with an emphasis on the early stage strategies needed to establish feasibility of the project. Additional peptide case studies from early to late stage development along with challenges encountered and lessons learned will also be presented. Additional topics to be discussed include: • What goes into a US Investigational New Drug (IND) application? • What research or formulation development work is needed? • What toxicology work is needed? • Simple versus complex formulations and delivery options and life-cycle management 12:00 Networking Luncheon for Workshop Attendees 1:00 Workshop Opening Remarks 2:30 Refreshment Break 4:00 Close of Workshop Post-Conference Workshop Schedule Silver Sponsors Agilent’s Nucleic Acid Solutions Division offers industry leading experience to efficiently advance your lead oligo candidates from clinic to market with a common goal of patient health and safety. With Agilent, you always have peace of mind by partnering with a company that has the financial resources, stability and vision required for long-term success. Contact us at: pdl-oulderinfo@agilent.com and find out why the world’s most revolutionary biotech companies and their Big Pharma partners are choosing Agilent Technologies to develop and commercialize their oligo APIs. Bachem specializes in the manufacture of peptides and complex small molecules as APIs as well as innovative biochemicals for research purposes. We offer technical consultancy, comprehensive regulatory affairs support, and dedicated project management from drug development through commercial scale cGMP production. Headquartered in Bubendorf, Switzerland with affiliates in Europe and the U.S. Established in 1981, ChemGenes, an ISO9001 certified company, has consistently provided the highest quality Phosphoramidites and Solid Supports in the market and continues to lead the industry in oligonucleotide reagent manufacturing. Our Massachusetts facility is setup for Bulk Therapeutic Grade phosphoramidite production for GMP grade oligonucleotide manufacturing. Additionally, ChemGenes carries the widest variety of modified phosphoramidites and supports currently used in oligonucleotide synthesis including Microarray Technology, Oligonucleotide Therapeutics, Oligonucleotide Based Probes and other areas of Nucleic Acid research. ChemGenes remains devoted to providing you with invaluable customer service and comprehensive technical support. Lonza offers the life sciences market a full range of bioresearch products, development services and manufacturing for active ingredients. For 30 years we have been helping companies increase product quality, improve production processes, navigate regulatory hurdles, lower costs, and get to market faster. From early development to in-market supply, our complete development services, industry-leading manufacturing processes, broad technology platform and lifecycle management experience can help take your product to the next level. For flexible, high-quality manufacturing, development services and products, we can help. Driven by Excellence, Guided by Experience. When you partner with Avecia, (www.Avecia.com) you will be working with the leading oligonucleotide CMO. Avecia offers the most extensive process validation experience in the oligo industry. As a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the future of the oligonucleotide market. We offer our customers oligo manufacturing capacity in two separate facilities (MA and OH). Our Cincinnati facility also provides expanded pre-clinical oligo services (OliGROW), as well as small molecule expertise and production. Our aim is to leverage our wealth of experience, to ensure we exceed our customer’s expectations. Avecia has the stability and vision required for the long-term success of your oligo program. The PolyPeptide Group is a leading provider of proprietary GMP, generic and non-GMP peptides and peptide conjugates for the pharmaceutical, cosmetic, and biotech industries as well as basic research. With 6 GMP facilities located across 3 continents, the Group supports peptide projects at all scales from pre-clinical through to commercialization. Bronze Sponsors Polyphor is a Swiss Pharma company focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. These macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. Polyphor`s proprietary technologies are broadly applicable to a wide array of biological targets and disease areas and already delivered a rich pipeline of pre-clinical and clinical drug candidates. Waters Division creates business advantages for laboratory- dependent organizations by delivering ultra performance liquid chromatography (UPLC), high performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality GeneDesign specializes in contract development and manufacturing of oligonucleotides therapeutics and diagnostics from screening stage to commercial stage. Session Sponsors Networking Reception Co-Sponsors Exhibitors(As of October 2, 2015) Agilent Technologies Inc Bachem AG BCN Peptides S.A. ChemGenes Corporation GeneDesign Inc Hongene Biotechnology Ltd Kinovate Life Sciences Inc Lonza Nitto Avecia Polypeptide Group ST Pharm Connect with 200+ Oligo and Peptide Decision Makers Reserve Your Exhibit Booth or Sponsorship Today! • Showcase your latest technology to our targeted audience of key decision-makers • Build invaluable relationships and form new partnerships that give you a competitive advantage in the US, Europe and Asia-Pacific • Gain international exposure through our specialized marketing campaign Call today to learn about the cost effective ways to drive lead generation and network with key buyers, including: Turn Key Exhibit Booth Packages, Event Partner Packages; Spotlight Session and Luncheon Briefing Sponsorships; Custom Emails, and Meeting Space For more information on how you can connect with these key buyers, contact: Patrick Gallagher • Tel: 617-512-6656 Email: pgallagher@ibcusa.com
  • 8. Payment Payment must be received 10 business days prior to the event. To take advantage of discounts with an expiry cut-off date, registration and payment must be received by the cut-off date. • Payments by USD bank draft or cheque should be made in favour of “IBC Asia (S) Pte Ltd” and mailed to: IBC Asia (S) Pte Ltd c/o Informa Regional Business Services 111 Somerset Road, TripleOne Somerset #10-06, Singapore 238164 Attn: The Accounts Receivable Team • Payment by telegraphic transfer in USD must be made to: IBC Asia (S) Pte Ltd A/C No.: 260-457866-178 (USD) The Hongkong and Shanghai Banking Corporation Limited, 21Collyer Quay, HSBC Building, Singapore 049320 Bank Swift Code: HSBCSGSG Bank Code: 7232 • Payment by Credit Card (AMEX, VISA or MASTERCARD) Please provide your Card Number, Name of Cardholder, Expiry Date and Signature and send it by fax to +65 6508 2407. Important Note Please quote the name of the delegate, event title and invoice number on the advice when remitting payment. Bank charges are to be deducted from participating organisations’ own accounts. Please fax your payment details (copy of remittance advice, cheque or draft to +65 6508 2407). Attendance will only be permitted upon receipt of full payment. Participants wishing to register at the door are responsible to ensure all details are as published. IBC assumes no further liability or obligation, beyond the refund of the paid registration fee, in the event of postponement or cancellation by IBC. Registration Substitutions/Cancellations Should you be unable to attend, a substitute delegate is welcome at no extra charge. Cancellations must be received in writing at least 10 business days before the start of the event, to receive a refund less 10% processing fee per registration.The company regrets that no refund will be made available for cancellation notifications received less than 10 business days before the event. IBC reserves the right to cancel or alter the content and timing of the program for reasons beyond its control and will NOT be held accountable for any costs incurred by the participants. Speakers are subject to change without prior notification. Data Protection The personal information entered during your registration/ order, or provided by you, will be held on a database and may be shared with companies in the Informa Group in the UK and internationally. Occasionally, your details may be obtained from or shared with external companies who wish to communicate with you offers related to your business activities. If you do not wish your details to be used for this purpose, please contact our Database Department at Email: database@ibcasia.com.sg, Tel: +65 6508 2400 or Fax: +65 6508 2408. Please tick: o I enclose my Cheque/Draft payable to IBC Asia (S) Pte Ltd o I am paying by bank transfer (copy attached) o Payment by Credit Card: o Amex o Visa o Mastercard Credit Card Payments: The best way to pay by credit card is through our secure on-line registration process, simply log on to the website at www.IBCLIfeSciences.com/AsiaTIDES and click “Register Now”. If you would prefer to pay over the phone please complete the contact name and details and someone from our Customer Services Team will call within 24 hours to take payment. As we treat your credit card information in the strictest confidence, please do not send payment details by email. Credit Card Contact:______________________________________ Department:_________________________________________ Direct phone number:____________________________________ Email:________________________________________________ Name: Dr/Mr/Ms_______________________________________ E-Mail______________________________________________ Job Title____________________________________________ Mobile no____________________________________________ Department__________________________________________ Company____________________________________________ Address_____________________________________________ Post Code____________________________________________ Tel________________________________________________ Main Business/Activity____________________________________ Name Title of Approving Manager____________________________ Name Title of Training Manager_____________________________ Industry Rates SAVE USD400 by Nov. 20, 2015 SAVE USD300 by Dec. 18, 2015 SAVE USD200 by Jan. 15, 2016 SAVE USD100 by Feb. 5, 2016 Standard Rate After Feb. 5, 2016 o Main Conference + Workshop* USD 1,899 USD 1,999 USD 2,099 USD 2,199 USD 2,299 o Main Conference Only USD 1,599 USD 1,699 USD 1,799 USD 1,899 USD 1,999 Group Rates (3+ from same company) SAVE USD400 by Nov. 20, 2015 SAVE USD300 by Dec. 18, 2015 SAVE USD200 by Jan. 15, 2016 SAVE USD100 by Feb. 5, 2016 Standard Rate After Feb. 5, 2016 o Main Conference + Workshop* USD 1,699 USD 1,799 USD 1,899 USD 1,999 USD 2,099 o Main Conference Only USD 1,399 USD 1,499 USD 1,599 USD 1,699 USD 1,799 *Select one Post-Conference Workshop: o Workshop #1: Current Status of Oligonucleotide Drug Delivery Approaches and Systems (DDS) o Workshop #2: Peptide Formulations: Regulatory Considerations for Early Clinical Research Academia/Government Discounts – 40% Savings: Academic and government employees are eligible for over 40% savings compared to the industry fees. Rate extended to full-time employees of government, universities and university- affiliated hospitals who have NO affiliation to a for profit entity. See website for details. Present a Poster o USD125 - Commercial o FREE - Academic o Attend Networking Dinner (Tuesday, February 24, 2016 • 6:45pm) USD120 Please tell us your primary area of interest: o Oligonucleotides o Peptides Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for the same event, at the same time. Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR special rate OR group rate. All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel. Registration fees are subject to the prevailing government tax. If undelivered, please return to: 111 Somerset Road TripleOne Somerset #10-06, Singapore 238164 Tel: +65 6508 2400 Fax: + 65 6508 2408 RESERVE YOUR PLACE TODAY! This label contains your priority booking code. To expedite registration, please do not remove label. If you have already received a copy of this brochure, we apologise. For reasons of confidentiality, your full particulars were not available to IBC Asia (S) Pte Ltd for deduplication prior to mail drop. SaveUpToUSD400 withtheEarlyBirdRates! Groups of 3+ Save an Additional USD200 per person. See below for details! AsiaTIDES – Oligonucleotide and Peptide® Research, Technology and Product Development P46303 REGISTER NOW! FAX BACKTO (65) 6508 2407 OR EMAILTO REGISTER@IBCASIA.COM.SG EASIEST: www.IBCLifeSciences.com/AsiaTIDES CALL +65 6508 2401 EMAIL register@ibcasia.com.sg 5 WAYS TO REGISTER FAX + 65 6508 2407 IBC Asia (S) Pte Ltd c/o Informa Regional Business Services 111 Somerset Road, TripleOne Somerset #10-06, Singapore 238164 MAILthe attached registration form with your cheque to Priority Code: R16225pdfwdl